Aurobindo Pharma's subsidiary seeks marketing approval of its first biosimilar product from EMA
Aurobindo Pharma is developing biosimilars for global markets through its subsidiary CuraTeQ Biologics with focus on oncology and immunology segments.
September 23, 2021 / 02:53 PM IST
"We remain on track for filing our second product, another oncology biosimilar in the regulated markets, in this calendar year," said Dr. Satakarni Makkapati, CEO of CuraTeQ. [Representative image]
Aurobindo Pharma, on September 23, announced that its subsidiary has submitted an application to the European Medicines Agency (EMA) seeking marketing approval of its Pegfilgrastim biosimilar.
This will be the first biosimilar product from Aurobindo's pipeline. Aurobindo is developing biosimilars for global markets through its subsidiary CuraTeQ Biologics with focus on oncology and immunology segments.
The BP14 - the biosimilar version of Aurobindo's pegfilgrastim boosts neutrophils, a type of white blood cells that are damaged due to chemotherapy in cancer patients.
"The submission of BP14 MAA with EMA is an important beginning in our business evolution and positions CuraTeQ well in our mission of providing access to high quality biosimilars for cancer patients," said Dr. Satakarni Makkapati, CEO of CuraTeQ.
"We remain on track for filing our second product, another oncology biosimilar in the regulated markets, in this calendar year," Satakarni said.
Satakrani added that CuraTeQ has completed a successful Phase 1 clinical trial of a monoclonal antibody biosimilar product used for the treatment of multiple types of cancers.
"Another biosimilar from our oncology portfolio, currently in Phase 3 clinical studies, has reached the 50 percent patient recruitment milestone this month and we hope to complete the recruitment in the next two quarters," Satakrani said.
"Our focus on executing parallel clinical studies for multiple biosimilars in the oncology segment is a testament of our commitment in expanding biosimilars treatment options for patients suffering from debilitating diseases," he added.
"I am pleased to see that our commitment to biosimilars business, backed by world-class infrastructure and high caliber team is starting to see positive momentum with our first regulatory filing, with more products in licensure clinical trials," K. Nithyananda Reddy, Vice Chairman of Aurobindo said.